Events

Recall of NXSTAGE SYSTEM ONE - CYCLER (CHRONIC APPLICATION)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NXSTAGE MEDICAL CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    154197
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Nxstage has identified a software error in the nxstage system one s cycler model no. nx1000-3 with software versions 4.9 and 4.10. if specific conditions are met and a software error does occur the ultrafiltration (uf) volume target will not decrease during the treatment even if the uf pump is running.

Device

NXSTAGE SYSTEM ONE - CYCLER (CHRONIC APPLICATION)
  • Model / Serial
    Model Catalog: (Lot serial: >10 numbers contact mfg)
  • Product Description
    NxStage System One-Cycler (Chronic Application)
  • Manufacturer
    NXSTAGE MEDICAL CANADA INC.

Manufacturer

NXSTAGE MEDICAL CANADA INC.